Fluorescence Polarization Immunoassay, Amibacin
A fluorescence polarization immunoassay for amikacin is a laboratory test that uses fluorescence polarization principles to measure amikacin, an aminoglycoside antibiotic, in patient specimens for therapeutic drug monitoring to ensure effective dosing and avoid nephrotoxicity or ototoxicity during treatment of serious bacterial infections. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LGJ and is regulated under 21 CFR 862.3035 within the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LGJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K991597 | COBAS INTEGRA AMIKACIN MAB | Jul 22, 1999 | Substantially Equivalent | Roche Diagnostics Corp. |
| K941712 | COBAS-FP REAGENTS AND CALIBRATORS | Jun 13, 1994 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K862248 | AMIKACIN KIT (FPIA) | Aug 04, 1986 | Substantially Equivalent | Windsor Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.